Panels › Microbiology › Product code GSN · Class 2
Antiserum, Positive And Negative Febrile Antigen Control Serum
Regulation 866.3085
0510(k)s in 12 months (3 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in GSN
| Company | 510(k)s | Recalls |
|---|---|---|
| BD Diagnostic Systems | 0 | 2 |
| Immuno-Mycologics, Inc. | 1 | 0 |
| Investigacion Farmaceutica S.A. DE C.V. | 1 | 0 |
| Sa Scientific, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 18, 1995 | K952145 | SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM Sa Scientific, Inc. | GSN |
| Aug 15, 1989 | K885113 | IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL Investigacion Farmaceutica S.A. DE C.V., MX | GSN |
| Aug 16, 1979 | K791385 | NEGATIVE CONTROL SERUM FOR CF RO ID Immuno-Mycologics, Inc. | GSN |
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